WO2020006607A1 - Guêtre de gestion de l'incontinence - Google Patents

Guêtre de gestion de l'incontinence Download PDF

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Publication number
WO2020006607A1
WO2020006607A1 PCT/AU2019/050711 AU2019050711W WO2020006607A1 WO 2020006607 A1 WO2020006607 A1 WO 2020006607A1 AU 2019050711 W AU2019050711 W AU 2019050711W WO 2020006607 A1 WO2020006607 A1 WO 2020006607A1
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WO
WIPO (PCT)
Prior art keywords
patient
micro
ankle cuff
controller
pulse
Prior art date
Application number
PCT/AU2019/050711
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English (en)
Inventor
Nicky Agahari
Original Assignee
Nicky Agahari
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from AU2018902463A external-priority patent/AU2018902463A0/en
Application filed by Nicky Agahari filed Critical Nicky Agahari
Priority to AU2019297205A priority Critical patent/AU2019297205B2/en
Priority to US17/258,284 priority patent/US20210268278A1/en
Publication of WO2020006607A1 publication Critical patent/WO2020006607A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/3603—Control systems
    • A61N1/36034—Control systems specified by the stimulation parameters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0472—Structure-related aspects
    • A61N1/0484—Garment electrodes worn by the patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0502—Skin piercing electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0551—Spinal or peripheral nerve electrodes
    • A61N1/0556—Cuff electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0219—Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A61B5/1116—Determining posture transitions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4806—Sleep evaluation
    • A61B5/4809—Sleep detection, i.e. determining whether a subject is asleep or not
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6829—Foot or ankle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6831—Straps, bands or harnesses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A61N1/0456—Specially adapted for transcutaneous electrical nerve stimulation [TENS]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0472—Structure-related aspects
    • A61N1/0476—Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36007—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of urogenital or gastrointestinal organs, e.g. for incontinence control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/36017—External stimulators, e.g. with patch electrodes with leads or electrodes penetrating the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/36021—External stimulators, e.g. with patch electrodes for treatment of pain
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/3603—Control systems
    • A61N1/36031—Control systems using physiological parameters for adjustment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37235—Aspects of the external programmer
    • A61N1/37247—User interfaces, e.g. input or presentation means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/08—Arrangements or circuits for monitoring, protecting, controlling or indicating
    • A61N2001/083—Monitoring integrity of contacts, e.g. by impedance measurement

Definitions

  • the present invention relates to an ankle cuff (and corresponding method of use) capable of producing a therapeutic effect for inhibiting and/or treating various urological conditions and gastrointestinal disorders. More particularly, but by no means exclusively, the present invention relates to an ankle cuff for managing incontinence in a patient.
  • Incontinence is considered as any involuntary loss of urine (urinary
  • incontinence or faeces (faecal or bowel incontinence).
  • faeces faecal or bowel incontinence
  • levels of incontinence may be experienced by a person, from minor leaks to complete loss of control of the bladder or bowel.
  • faecal incontinence Approximately 1 in 20 people suffer faecal incontinence, which can include the passing of both stool or wind involuntarily due to a lack of control. There are many causes of faecal incontinence, including the weakening of back passage muscles after having children, due to surgery, or as the result of aging.
  • Incontinence can be partially managed through lifestyle changes, such as performing physical activities that operate to engage and strengthen the pelvic floor. However, such activities, even when performed diligently, may only slightly improve the condition. Further, sufferers may find it difficult to perform such activities, for example, due to an aging physical frame.
  • Another option for sufferers of incontinence is to use continence products or aids, such as pads, condom drainages and speciality bed sheets. While providing a slightly improved quality of life to certain sufferers, such continence products do not treat the disorder and are therefore not a desirable long-term option.
  • tibial nerve neuromodulation to treat pelvic floor and gastrointestinal disorders.
  • the tibial nerve is a branch of the sciatic nerve and passes alongside the tibia into the foot. Stimulation of the tibial nerve has been found to block signals from the brain that can trigger incontinence, as well as to strengthen muscles to aid in preventing further episodes of
  • TENS machines are comprised of a set of bi- polar hydrogel electrode pads connected to a pulse generator. The bi-polar hydrogel electrode pads are placed on the skin with the negative electrode positioned directly above the tibial nerve and the positive electrode positioned within proximity of the negative electrode. The pulse generator then delivers an electrical pulse to the tibial nerve via the electrodes.
  • the anatomical location where the electrode pads are placed is often shaved, and hydrogel is applied to both the skin and the bottom of each of electrode pad. Once the electrode pads are suitably positioned, tape is used to secure them to the skin (commonly
  • transcutaneous electrodes are hydrogel based with a sticky surface that sticks to the surface of the skin), thereby preventing movement and the potential for unwanted surrounding nerve stimulation. This preparation is not only time consuming, but also requires periodic re-application due to tape degradation and hydrogel evaporation.
  • the frequency applied by a TENS machine is typically limited to 50Hz, as using higher frequencies may result in the unwanted stimulation of other surrounding nerves.
  • a downside to using such lower frequencies is that the patient may experience paraesthesia around the location of the electrode pads. This can cause discomfort to the patient.
  • percutaneous electrical nerve stimulation involves inserting a slim needle electrode through the skin which targets the tibial nerve. Due to the targeted nature of percutaneous tibial nerve stimulation, a higher frequency pulse can be applied to the tibial nerve, thus reducing the likelihood of a patient experiencing paraesthesia during treatment.
  • a doctor or trained medical professional is required to precisely insert the needle electrode below the epidermis, near the medial malleolus of a patient.
  • a second electrode is then positioned above the epidermis. Due to the procedure needing to be performed by a trained medical professional, this form of treatment is relatively costly. Further, due to the procedure being invasive, it can be painful and may result in inflammation and blood loss (which can in turn leave the patient susceptible to bacterial infections).
  • an ankle cuff for managing incontinence in a patient comprising: a body; a first micro- needle electrode array located on an inner face of the body; a second micro-needle electrode array separately located from the first micro-needle electrode array; a pulse generator electrically coupled to the first and second micro-needle electrode arrays; in use, the body is configured to be worn around an ankle of the patient such that individual micro-needles of the first and second micro-needle electrode arrays insert into an epidermis of the patient; and a controller, wherein the controller controls the pulse generator to pulse the first and second micro-needle electrode arrays to electrically stimulate the posterior tibial nerve for managing incontinence in the patient.
  • the first micro-needle electrode array is a negative electrode array that locates directly superior to the posterior tibial nerve and between a medial malleolus and an Achilles tendon of the patient.
  • the second micro-needle electrode array is a positive electrode array that locates between a lateral malleolus and the Achilles tendon.
  • the second micro-needle electrode array is located directly superior to a sural nerve of the patient.
  • first and second micro-needle electrode arrays each comprise a plurality of individual needles that have a depth of less than 1 mm and which are configured to pierce a stratum corneum layer of the epidermis.
  • the controller can program the plurality of individual needles of the first and second micro-needle electrode arrays to pulse at different amplitudes or frequencies determined by the controller.
  • the controller can program the plurality of individual needles to be grouped into two or more electrode zones that are adapted to pulse at different amplitudes or frequencies determined by the controller.
  • the first micro-needle electrode array and second micro-needle electrode array are detachable from the ankle cuff.
  • an ankle cuff for managing incontinence in a patient, comprising: a body; a first transcutaneous negative electrode located on an inner face of the body; a second transcutaneous positive electrode separately located from the first electrode; a pulse generator electrically coupled to the first and second transcutaneous electrodes; a controller, wherein the controller controls the pulse generator to pulse the first and second transcutaneous electrodes to electrically stimulate the posterior tibial nerve for managing incontinence in the patient; and wherein the first and second
  • transcutaneous electrodes are selected from: hydrogel electrodes, silver electrodes, platinum electrodes or metal electrodes.
  • first transcutaneous negative electrode and second transcutaneous positive electrode are detachable from the ankle cuff.
  • the pulse is of sufficient amplitude and frequency to at least partially relieve a symptom selected from: urgent urination, urinary retention, urge incontinence, frequent urination, mixed urinary incontinence, nocturia, interstitial cystitis, bladder discomfort, pelvic pain, faecal incontinence, constipation, irritable bowel syndrome, nocturnal enuresis, erectile dysfunction and persistent pelvic pain.
  • a symptom selected from: urgent urination, urinary retention, urge incontinence, frequent urination, mixed urinary incontinence, nocturia, interstitial cystitis, bladder discomfort, pelvic pain, faecal incontinence, constipation, irritable bowel syndrome, nocturnal enuresis, erectile dysfunction and persistent pelvic pain.
  • the controller is configured to collect acceleration data output by the accelerometer.
  • the acceleration data is evaluated by the controller to determine at least one of a desirable time, amplitude and frequency to electrically stimulate the posterior tibial nerve and manage incontinence in the patient.
  • the controller is configured to evaluate acceleration data captured during a sleep time of the patient to determine potential nocturia events and wherein the determined nocturia events are recorded and classified as such.
  • the classified potential nocturia events are evaluated over time to predict future nocturia events for the patient and wherein the controller controls or suggests to the patient controlling the pulse generator prior to the predicted respective future periods.
  • the controller is configured to control the pulse generator to pulse at a higher amplitude for a predetermined period before the predicted future nocturia events.
  • the predetermined period is between 1 and 40 minutes before the predicted the future nocturia events.
  • the controller determines that the patient is moving based on the collected accelerometer data
  • the controller is configured to control the pulse generator to pulse the electrodes at a lower amplitude than if the patient were stationary.
  • the controller determines that the patient is stationary when an acceleration of the patient is between O.Om/s - 2.0m/s, otherwise the patient is determined to be moving.
  • a gyroscope that is configured to output positional data of the patient and wherein the controller evaluates the positional data to determine whether the patient is standing, sitting or lying down.
  • the controller controls at least one of an amplitude and frequency of the pulse based on the positional data.
  • the pulse frequency is between 1 Hz to 100kHz.
  • the pulse amplitude is between 0.1 m Amps to 12.0m Amps.
  • a method of stimulating a posterior tibial nerve of a patient comprising; identifying a medial malleolus of the patient; placing a wearable ankle cuff on the patient such that the medial malleolus locates within a predetermined medial malleolus location of the wearable ankle cuff; pulsing a pair of electrodes located on an inner face of the wearable ankle cuff so as to stimulate the tibial nerve for managing incontinence in the patient.
  • the pair of electrodes are micro-needle electrode arrays.
  • a first of the pair of electrodes is a negative micro-needle electrode array that locates directly superior to the posterior tibial nerve and between a medial malleolus and an Achilles tendon of the patient.
  • a second of the pair of electrodes is a positive micro-needle electrode array that locates directly superficial or superior to a sural nerve of the patient and between a lateral malleolus and the Achilles tendon.
  • a removeable insert for an ankle cuff comprising: a first transcutaneous electrode; a second transcutaneous electrode; and a region adapted to couple to the ankle cuff such that the first and second electrode can receive a pulse from a pulse generator of the ankle cuff.
  • Figure 1 is a medial side view of an ankle cuff worn by a patient, in
  • Figure 2 is an end view of the ankle cuff shown in Figure 1 worn by the patient;
  • Figure 3 is a perspective view of the ankle cuff of Figure 1 (removed from the patient) illustrating internally disposed electrode arrays;
  • Figure 4 is a medial side view of a patient’s ankle illustrating anatomical land marks for positioning the ankle cuff of Figure 1 ;
  • Figure 5 is a lateral side view of a patient’s ankle illustrating anatomical land marks for positioning the ankle cuff of Figure 1 ;
  • Figure 6 is a lateral side view of the ankle cuff of Figure 1 , in accordance with an embodiment of the present invention.
  • Figure 6 is a lateral side view of the ankle cuff of Figure 1 , in accordance with an embodiment of the present invention.
  • FIG. 7a, 7b and 7c are schematics showing electrode arrays partitioned into multiple zones, in accordance with an embodiment of the present invention
  • Figure 8 is a schematic showing a removable insert for the cuff of Figure 1 , in accordance with an embodiment of the invention.
  • Figures 9a and 9b are schematics illustrating the cap and socket of the snap fasteners in accordance with an embodiment of the present invention.
  • Embodiments of the invention described herein relate to an ankle cuff configured to stimulate a patient’s posterior tibial nerve for managing urological and gastrointestinal conditions without unwanted sensory and/or motor side effects.
  • Management may include inhibiting, supressing, down regulating, blocking, preventing or otherwise neuromodulating the activity of the affected neural population.
  • the ankle cuff may be used, for example, for managing overactive bladder systems including urgency, incontinence and frequency, mixed urinary incontinence, interstitial cystitis, urinary retention and persistent pelvic pain.
  • Gastrointestinal disorders that can be managed by an ankle cuff as described herein, including faecal incontinence, constipation and irritable bowel syndrome.
  • an ankle cuff as described herein comprises a body configured to be worn around the ankle of a patient.
  • a first and second electrode array are each located on an inner face of the body and positioned to accurately target the patient’s posterior tibial nerve.
  • a cuff controller controls a pulse generator that is electrically coupled to the first and second electrode arrays for pulsing the electrodes (across a variable range of frequencies and wavelengths) to electrically stimulate the targeted tibial nerve for managing the condition.
  • the ankle cuff (1 ) comprises a body (1 a) configured to be worn around an ankle of a patient.
  • the electrode arrays take the form of micro-needle arrays.
  • a negative micro-needle electrode array (3) is located on an inner face (1 b) of the body (1 a) superior to at least a portion of the patient’s posterior tibial nerve (2).
  • a positive micro-needle electrode array (4) is also located on the inner face of the cuff body (1 a) separate from the first micro-needle electrode array (3).
  • Each micro-needle electrode array (3, 4) comprises of a plurality of individual needles that, according to the illustrated embodiment, are less than or equal to 1 mm long.
  • the individual needles are closely spaced such that the large electric fields needed for electroporation can be achieved at relatively low voltages.
  • placing the micro-needle arrays (3, 4) in the illustrated locations results in low interface impedance while allowing for a highly localised pulse for effective
  • the micro-needle electrode arrays (3, 4) When worn as shown in Figures 1 and 2, the micro-needle electrode arrays (3, 4) are applied to the patient’s skin at a low compression force, piercing only the stratum corneum layer. This is painless for the patient as no pain receptors are triggered, nor is any blood drawn. This minimises patient discomfort and risk of infection after removal of the cuff (1 ). Further, since the micro-needle arrays (3, 4) are dry electrodes they do not require any form of moisture (i.e. hydrogel, water, etc) to provide an effective pulse and can therefore be applied to the skin without the need for any specific preparation or additional equipment.
  • moisture i.e. hydrogel, water, etc
  • the body (1 a) is configured to open for receiving the patient’s ankle and close for securing around the patient’s ankle.
  • the body (1 a) is formed of two hinged parts (1 c, 1 d) that releasably couple at a non- hinged end for opening and closing around the patient’s ankle.
  • the non-hinged end is located adjacent the patient’s Achilles tendon (6).
  • a clasp 1 (e) is provided for releasably coupling the two parts (1 c, 1 d) at the non-hinged end (though it will be understood that any suitable means could be used for releasably coupling the two parts).
  • the body (1 a) may take the form of a single length of strap that is configured to wrap around the patient’s ankle, with the ends being secured by way of a magnets, clip, buckle, VelcroTM, zipper, or other suitable securing means.
  • the body (1 a) is advantageously configured such that the negative micro- needle electrode array (3) always locates directly superior to the posterior tibial nerve (2), as will now be described with additional reference to Figure 4.
  • the tibial nerve (2) is located between a medial malleolus (5) and an Achilles tendon (6) of the patient.
  • the medial malleolus (5) is a bony protrusion on the inner ankle.
  • the cuff (1 ) uses at least one of these two anatomical land marks for positioning so that it can consistently locate the negative array (3) directly above the posterior tibial nerve (2).
  • the body (1a) of the cuff (1 ) comprises a medial aperture (5a) that is sized and shaped to receive the medial malleolus (5).
  • the negative micro-needle electrode array (3) is disposed on the inner face 1 b between the aperture (5a) and the clasped end.
  • the cuff (1 ) is located over the patient’s ankle such that the medial aperture (5a) surrounds the medial malleolus (5) and sits generally flush about the surrounding skin (thereby exposing the medial malleolus’s bony ridge). This is best shown in Figures 1 and 2.
  • the positive micro-needle electrode array (4) may be located in any suitable location on the inner wall (1 b) of the body (1 a) separate from the negative electrode array (3). Flowever, according to the illustrated embodiment, the positive array (4) is located directly superior to the sural nerve (see Figure 5 sans cuff (1 ) for ease of reference). This configuration has the benefit of additionally stimulating the sural nerve (10) which has been found to reduce the potential for paraesthesia.
  • a lateral aperture (11 b) in the cuff body (1 a) is configured to locate over the lateral malleolus (11 ) in the same manner as for the medial aperture (5a). It will be understood that the cuff (1 ) may incorporate only a medial or lateral aperture, however, while still allowing for accurate positioning of the electrode arrays (3, 4).
  • the ankle cuff (1 ) further comprises a controller (9) adapted to control a pulse generator (9a) for pulsing the micro-needle electrode arrays (3, 4).
  • the controller (9) and pulse generator (9a) are powered by an integrated battery.
  • the controller (9) may, for example, comprise a microcontroller having a wireless transceiver for receiving patient commands from a remote device.
  • the controller (9) may comprise a wireless transceiver (e.g. Bluetooth) for communicating with a mobile phone or other suitable electronic device having an input device (e.g. keyboard, touch screen interface, etc.) and loaded with software capable of communicating with the controller (9)).
  • the controller (9) may be communicable with one or more controls located on the ankle cuff (1 ) for receiving patient commands.
  • a“pulse” button may be provided on the ankle cuff (1 ) which causes the controller (9) to instruct the pulse generator (9a) to pulse the electrode arrays (3, 4).
  • the pulse applied by the pulse generator (9a) is of sufficient amplitude and frequency to at least partially relieve a symptom selected from: urgent urination, urinary retention, urge incontinence, frequent urination, mixed urinary incontinence, nocturia, interstitial cystitis, bladder discomfort, pelvic pain, faecal incontinence, constipation, irritable bowel syndrome, nocturnal enuresis, erectile dysfunction and persistent pelvic pain.
  • correct positioning is determined by noting a motor response when the pulse amplitude is increased to create halux reaction (plantar flexion of great toe or fanning of all toes), or where the patient notes a tingling sensation, pulsing, or movement in the great toe.
  • pulse parameters The amplitude, frequency and wavelength of pulse (hereafter“pulse parameters”) necessary to stimulate the tibial nerve may vary from patient to patient.
  • pulse parameters include pulse parameters, frequency and wavelength of pulse (hereafter“pulse parameters”) necessary to stimulate the tibial nerve.
  • micro-needle electrode arrays (3, 4) may be split into one or more zones (7) of individual electrodes, as
  • the zones (7) may be predefined by the controller (9) or manually determined by the patient (via their electronic input device). According to the illustrated embodiment depicted in Figures 7a and 7b, the negative micro-needle electrode array (3) is split into four predefined zones (7a, 7b, 7c, 7d), while the positive micro-needle electrode array (4) is split into two predefined zones (7e, 7f). Persons skilled in the art will appreciate that the zones (7) may be the same or different sizes and that each array can include any number of zones (7).
  • Figure 7c is a side view illustrating the needles of the positive and negative micro- needle electrode arrays (3, 4).
  • a patient may select a number of parameters for each zone (7), including, but not limited to, the pulse parameters for each zone (7), as well as whether the zones (7) are to be“on” (pulsed) or“off” (not pulsed) during a pulsing session.
  • the patient may instruct the controller (9) to select zone parameters based on personal preference. For instance, through trial and error the patient may determine that when an upper two zones of the negative micro-needle electrode array (3) are in an “off” state they experience less paraesthesia.
  • either uniformed and un- uniformed electrical stimulation can be directed towards the posterior tibial nerve (2) by way of the arrays (3, 4). Un-uniformed stimulation may require less battery power to be used for generating sufficient amplitude directed towards the posterior tibial nerve (2). Further, by being able to tailor individual amplitudes for each needle on the surface of the micro-needle electrode array, the ankle cuff (1 ) may be able to deliver targeted stimulation towards the patient’s posterior tibial nerve (2). For example, the micro-needles closest to the posterior tibial nerve (2) may be
  • the electrode arrays (3, 4) are disposed on or within the insert (8), allowing them to be replaced without the need to replace the entire ankle cuff (1 ).
  • the removable insert (8) may be attached to the inner wall (1 b) of the cuff (1 ) via a fastening means such as VelcroTM, snap lock clips, adhesive, or other suitable fastening means.
  • the removable insert (8) is formed of a soft fabric material.
  • An electrical connection between the arrays (3, 4) and the pulse generator (9a) may be made by way of conductive snap fasteners (9) illustrated in Figures 9a and 9b.
  • the snap fasteners (9) are comprised of a cap (9a) disposed on the insert (8) and a socket (9b) disposed on the inner wall (1 b) of the cuff (1 ).
  • the ankle cuff may comprise non-micro needle electrode arrays, including transcutaneous electrodes such as hydrogel electrodes, silver electrodes, platinum electrodes or metal electrodes. Further, the ankle cuff may comprise a combination of
  • transcutaneous electrodes and percutaneous electrodes such as electrodes comprised of a hydrogel base with micro needle electrode arrays embedded onto the hydrogel base.
  • a sub-threshold amplitude and motor activation amplitude may be determined either automatically or by the patient.
  • the sub-threshold amplitude may be an amplitude where the tibial nerve is stimulated, but no paraesthesia or planar foot flexion is experienced.
  • the motor activated amplitude activates a motor response such as paraesthesia of planar foot flexion.
  • These values may be the same or different in the supine (horizontal) position, Fowler’s partition (when sitting) and a standing position (vertical).
  • the controller (9) may be programmed to consistently stimulate the posterior nerve (2) at the sub-threshold amplitude for strengthening the patient’s muscles.
  • sub-threshold amplitude and motor activation amplitude will vary dependant on a number of factors including but not limited to; patient physiology, xeroderma (dry skin), electrical impedance, position of electrodes, position of nerves, body position, etc.
  • high frequency pulse modulation of between 3khz to 100khz is desirable to significantly reduce paraesthesia side effects and neural motor activation.
  • These high frequencies can be applied by the controller (9) in a cycling mode, such that the pulse is applied for between 1 m/s - 2m/s and then stopped for 1 m/s - 1 m/s.
  • the pulse amplitude is desirably set between 0.1 m Amps to 12.0m Amps.
  • the pulse generator (9a) may controlled to send pulses at increasing amplitude until a neural motor response is activated, or until paraesthesia is felt in the area surrounding the electrodes.
  • the controller (9) is programmed to monitor electrical impendence levels between the skin and the electrode arrays (3, 4) and automatically adjust amplitude levels (i.e. based on the resulting levels) to reduce the risk of overstimulation resulting in severe burns and pain. For example, if only a small area of the micro-needle electrode array is providing a pulse with the desired current (e.g. due to electrode peeling), the controller (9) will decrease or even cease the pulse to prevent burn and discomfort.
  • the ankle cuff (1 ) further comprises an accelerometer (12).
  • the accelerometer (12) may be positioned on the cuff (1 ) in any suitable location.
  • the controller (9) is configured to collect data output by the accelerometer (hereafter“acceleration data”) when the ankle cuff (1 ) is worn by the patient.
  • the acceleration data may be evaluated by the controller (9) to determine at least one of a desirable time, amplitude and frequency to electrically stimulate the posterior tibial nerve for managing incontinence in the patient.
  • the controller (9) is programmed to evaluate acceleration data captured while the patient is sleeping to determine and record potential nocturia events. In one embodiment the patient tells the controller (9) when sleep time is to commence (e.g. using their input device). Alternatively, the controller (9) may automatically make this determination based on an evaluation of the acceleration data and current time. For example, the controller (9) may be programmed to recognised that the patient is asleep when they have remained still for more than 10 minutes after 9pm at night.
  • the controller (9) is programmed to register a potential nocturnal event when the patient moves during the night for more than a predefined period.
  • the patient may subsequently validate this registration using their input device.
  • the acceleration data may be evaluated over time to predict future nocturia events. For example, acceleration data collected over a three-day period may indicate that a patient consistently experiences a nocturia event at 11 pm and 3am every night. As such, a prediction is made that future nocturia events will occur at 11 pm and 3am subsequent nights.
  • the controller (9) can then acutely stimulate the posterior tibial nerve (2) before the predicted nocturia event with the aim of preventing those events from happening. The stimulation may occur anywhere between 1 second and 2 hours before the predicted future nocturia event, depending on the patient.
  • the controller (9) will instruct the pulse generator (9a) to pulse at a higher amplitude before the predicted future nocturia event.
  • the acceleration data could be collected over any number of days for determining nocturia event trends.
  • the controller (9) can be programmed to continuously collect acceleration data to determine when the patient is accelerating so that the pulsing can either be ceased, or the pulse amplitude decreased during this time. Ceasing or decreasing the amplitude may also minimise any discomfort and unwanted motor activation that can inhibit the patient while walking or running.
  • the ankle cuff (1 ) further comprises a gyroscope (13).
  • the gyroscope (13) is configured to output positional data of the patient by measuring orientation and angular velocity of the cuff (1 ).
  • the controller (9) is adapted to evaluate the positional data to determine whether the patient is standing, sitting or lying down. Based on the orientation of the patient, one or more pulse parameters may be adjusted. For example:
  • each independent feature or component of any given assembly may constitute an additional embodiment.

Abstract

L'invention concerne une guêtre pour gérer l'incontinence chez un patient, comprenant : un corps ; un premier réseau de micro-aiguilles d'électrode situé sur une face interne du corps ; un second réseau de micro-aiguilles d'électrode situé séparément du premier réseau de micro-aiguilles d'électrode ; un générateur d'impulsions couplé électriquement aux premier et second réseaux de micro-aiguilles d'électrode ; lors de l'utilisation, le corps étant conçu de façon à être porté autour d'une cheville du patient de sorte que des micro-aiguilles individuelles des premier et second réseaux de micro-aiguilles d'électrode s'insèrent dans l'épiderme du patient ; et un dispositif de commande, le dispositif de commande commandant le générateur d'impulsions de façon à ce que les premier et second réseaux de micro-aiguilles d'électrode transmettent des impulsions de façon à stimuler électriquement le nerf tibial postérieur pour gérer l'incontinence chez le patient.
PCT/AU2019/050711 2018-07-06 2019-07-05 Guêtre de gestion de l'incontinence WO2020006607A1 (fr)

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AU2019297205A AU2019297205B2 (en) 2018-07-06 2019-07-05 An ankle cuff for managing incontinence
US17/258,284 US20210268278A1 (en) 2018-07-06 2019-07-05 An ankle cuff for managing incontinence

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AU2018902463A AU2018902463A0 (en) 2018-07-06 An ankle cuff
AU2018902463 2018-07-06

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